ImageBiocon was scouting for more strategic alliances and exploring opportunities for outlicensing its biotech drugs under development, as it pitches for a slot among the top three bio-pharmaceutical players across the globe, said Kiran Mazumdar-Shaw, chairman and managing director.

Biocon hums with plans, pitches for global top 3 slotThe company, which recently entered into a tie-up with Mylan Pharmaceuticals of the US to develop and market four biosimilar products (off-patent biotech drugs), is looking at similar opportunities with other players.
Mylan and Biocon may also expand the existing pact, depending on the way the regulatory framework for biosimilars evolves in the coming years, she said.
"The potential of biosimilars is so huge and there will be opportunities. Development of each of the products requires $50-100 million investment for global operations and we are planning to follow a partnership model," she said.

About $25 billion worth of biological drugs are losing patent protection by 2016, and it is predicted that seven of the 10 top-selling drugs will be biologics by 2020. Anticipating the opportunity, Indian companies such as Biocon, Wockhardt, Dr Reddy's Laboratories and Intas Biopharmaceuticals are developing a big portfolio of such products.

Biocon has already made a string of alliances in recent years. Apart from the Mylan alliance, it got Neopharma of Abu Dhabi to market products in the West Asia and Amylin Pharma of the US to develop a potential treatment of diabetes. And, with an undisclosed American company to sell insulin in the US market.

Mazumdar-Shaw said Biocon would share about 30 per cent of the product development costs with Mylan and, in turn, get milestone payments. The partners will share profits. The company has already got a Rs 10 crore (Rs 100 million) milestone payment in the last quarter.

She said Biocon was also planning to outlicense its oral insulin and a psoriasis drug under development once its safety and efficacy was established after clinical trials.

Its oral insulin is in the final round of clinical trials on over 300 volunteers in India. This data will be out by the middle of next year. It is the only insulin under development in tablet form. Biocon is also planning to begin the final round of human clinical trials of T1h, the drug under development for rheumatoid arthritis by next year, and for psoriasis within two months.

"We plan to file investigational new drug (IND) applications with the US Food and Drug Administration (FDA) by next year for oral insulin and psoriasis. The data of Indian trials will help to speed up regulatory clearances from the FDA and thereby help to reduce costs," said Arun Chandavarkar, chief operating officer.

Development of a new drug costs over $1 billion and takes 1-15 years of pre-clinical and clinical development in three phases to reach the commercialization stage.

Mazumdar-Shaw said the company, now among the top 20 biotech firms in the world and the only one to feature from India, is also the seventh largest employer among biotech companies, with over 3,600 employees. The company is likely to post a revenue of $500 million in the current year.

Commenting on the initial public offer of its contract research and clinical trial arms, Syngene and Clingene, she said the two companies would be merged into a single entity before the IPO, likely by the end of next year. Together, the firms had generated about Rs 137 crore (Rs 1.37 billion) revenue for the first half of 2009-10.